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Hikma Injectables FDA-483 Out

[ Price : $8.95]

FDA releases the form FDA-483 with four observations from an inspection at the Dayton, NJ-based Hikma Injectables USA outsourcing ...

Researchers Affirm Mifepristone Safety to FDA

[ Price : $8.95]

More than 260 reproductive health researchers urge FDA to continue to support mifepristone based on its 25-year record of safety a...

FDA Looking at MASH Surrogate

[ Price : $8.95]

FDA says it has accepted an Echosens Letter of Intent to develop Liver Stiffness Measurement by Vibration-Controlled Transient Ela...

Grace Therapeutics NDA for Hemorrhage Drug Submitted

[ Price : $8.95]

FDA accepts for review a Grace Therapeutics NDA for GTx-104 (nimodipine for injection) for treating patients with aneurysmal subar...

Limited Covid Vaccines OKd for Upcoming Season

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FDA approves supplemental BLAs from Moderna and Pfizer/BioNTech for their mRNA Covid-19 vaccines that target the LP.8.1 variant of...

Regeneron to Seek FDA OK for Myasthenia Gravis Drug

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Regeneron Pharmaceuticals releases favorable Phase 3 data for its RNA-based therapy cemdisiran and says it will seek FDA approval ...

Lilly Plans NDA for Obesity Pill; Positive Data Released

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Eli Lilly plans to seek approval for its investigational obesity pill orforglipron following positive topline results from the Pha...

QS Violations at LeMaitre Vascular

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FDA warns North Brunswick, NJ-based LeMaitre Vascular about Quality System Regulation and other violations in its manufacturing of...

Allaritys Stenoparib on FDA Fast Track

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FDA grants fast track designation to Allarity Therapeutics investigational ovarian cancer drug stenoparib.

Axogen Nerve Graft Review Extended by 3 Months

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FDA extends by three months its review of an Axogen BLA for Avance Nerve Graft after the agency determined that information submit...